Levonis

Package leaflet: Information for the patient

Levonis 0.1% nebulizer solution

Levonis adults nebulizer solution
Levonis children nebulizer solution
Flunisolide
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Levonis is and what it is used for
2. What you need to know before taking Levonis
3. How to take Levonis
4. Possible side effects
5. How to store Levonis
6. Contents of the pack and other information

1. What Levonis is and what it is used for

Levonis contains the active substance flunisolide, a corticosteroid with anti-inflammatory activity.
Levonis is indicated in allergic respiratory diseases:

• bronchial asthma, an inflammatory disease characterized by obstruction of the bronchi;
• chronic asthmatic bronchitis, a persistent inflammatory disease of the bronchi associated with breathing difficulties;
• rhinitis, inflammation of the inner part of the nose, either persistent (chronic) or seasonal.

2. What you should know before taking Levonis

Do not take Levonis

• if you are allergic to flunisolid or to any of the other ingredients of this medicine (listed in section 6);
• if you have a lung infection called active or quiescent pulmonary tuberculosis;
• if you have infections caused by microorganisms such as bacteria, viruses, or fungi;
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Levonis if:

• you have herpes simplex infection of the eyes;
• you have a history of past or recent nasal trauma, with lesions of the nasal septum that do not heal (ulcers) or with recurrent nosebleeds (epistaxis);
• you have changes in the microorganisms (microbial flora) present in the nose and throat (upper respiratory tract), particularly during prolonged treatment, contact your doctor, who may prescribe a concomitant therapy. Rarely, a series of psychological and behavioral effects may occur, including psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, and behavioral disorders (mainly in children).

Prolonged use, especially, of this medicine may lead to sensitization phenomena and, very rarely, systemic adverse effects involving the entire body may occur, such as loss of appetite (anorexia), abdominal pain, weight loss, fatigue, headache, nausea, vomiting; specific symptoms associated with inhaled corticosteroid therapy include hypoglycemia with reduced level of consciousness and/or seizures. In such cases, your doctor will discontinue treatment and initiate appropriate therapy.
Contact your doctor if you experience blurred vision or other visual disturbances.
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children and adolescents
Levonis is not recommended for children under four years of age.
Other medicines and Levonis
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of Levonis, and your doctor may decide to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine is not recommended during the first three months of pregnancy.
During the later stages of pregnancy and while breastfeeding, the medicine should be used only when clearly needed and under direct medical supervision.
Driving and using machines
No effects on the ability to drive or operate machinery are known.

3. How to take Levonis

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Adults
Levonis 0.1% nebulizing solution
The recommended dose is: 1 mg (25 drops) twice daily.
Each drop contains 40 micrograms of flunisolide.
Levonis adults nebulizing solution
The recommended dose is: half the content of one container of Levonis adults twice daily.
Children
Levonis 0.1% nebulizing solution
The recommended dose is: 500 micrograms (12–13 drops) twice daily.
Each drop contains 40 micrograms of flunisolide.
It is not recommended to administer to children under four years of age.
Levonis children nebulizing solution
The recommended dose is: half the content of one container of Levonis children twice daily.
It is not recommended to administer to children under four years of age.

Instructions for use

Levonis must be used with electric nebulizers and must not be diluted.

It is known that administering medicinal solutions via electric nebulizers results in a residual amount of solution adhering to the vial walls or remaining at the bottom, which is not delivered.
For this reason, when preparing the dose, it is necessary to take into account the need to compensate for this undelivered portion.
If you take more Levonis than you should
Administering large amounts of flunisolide within a short period of time may lead to suppression of certain important hormonal functions (hypothalamic-pituitary-adrenal function).
If you forget to take Levonis
Do not take a double dose to make up for the missed dose.
If you stop using Levonis
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
The following side effects have been observed:

• cough and hoarseness in patients with highly sensitive airways;
• occasionally mild and transient burning sensation inside the nose (mucosa);
• rarely, fungal infections in the mouth or throat, which quickly resolve with appropriate local treatment. These infections can be prevented or minimized by thoroughly rinsing the mouth after each administration;
• nasal irritation, nosebleeds (epistaxis), nasal congestion, nasal discharge (rhinorrhea), sore throat, hoarseness, and irritation of the mouth (oral cavity) and throat. If severe, these side effects may require discontinuation of therapy;
• only with excessive use of the medicine, typical effects of systemically administered glucocorticosteroids may occur, although to a reduced extent. These have commonly been observed in patients who have been taking glucocorticosteroids for a long time (corticosteroid-dependent), such as nasal congestion and nasal polyps. In case of prolonged treatment, patients should be kept under close medical supervision to promptly detect any possible systemic manifestations (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency such as hypotension and weight loss). With high doses used over long periods, suppression of the activity of the adrenal glands, growth retardation in children and adolescents, decreased bone mineral density, eye lens opacity (cataract), and prolonged damage to the optic nerve (glaucoma) may occur. Side effects that may occur with unknown frequency include:
• psychomotor hyperactivity;
• sleep disorders;
• anxiety;
• depression;
• aggression;
• behavioural disturbances (mainly in children);
• blurred vision (with unknown frequency).
  Following the instructions contained in this leaflet reduces the occurrence of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levonis

Levonis 0.1% nebulizer solution
Store below 25°C in the original packaging to protect the medicine from light.
Use the medicine within 30 days of first opening the vial. Any unused medicine must be discarded.

Levonis adults nebulizer solution
Levonis children nebulizer solution
Store in the original packaging to protect the medicine from light.
Use the medicine within 12 hours of first opening the container. Any unused medicine must be discarded.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after the word “Expiry”.
The expiry date refers to the last day of that month.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levonis contains
Levonis 0.1% nebulizing solution

• The active substance is flunisolide. 100 ml of solution contain 100 mg of flunisolide.
• The other components are propylene glycol, sodium chloride, water for injections.

Levonis adults nebulizing solution

• The active substance is flunisolide. One 2 ml container of solution contains 2 mg of flunisolide.
• The other components are propylene glycol, sodium chloride, water for injections.

Levonis children nebulizing solution

• The active substance is flunisolide. One 2 ml container of solution contains 1 mg of flunisolide.
• The other components are propylene glycol, sodium chloride, water for injections.

Description of the appearance of Levonis and package contents
Levonis 0.1% nebulizing solution
Nebulizing solution. 30 ml bottle of 0.1% solution.
One drop contains 40 micrograms of flunisolide.

Levonis adults nebulizing solution
Nebulizing solution.
Pack of 15 containers of 2 ml solution (2 mg/2 ml).

Levonis children nebulizing solution
Nebulizing solution.
Pack of 15 containers of 2 ml solution (1 mg/2 ml).

Marketing Authorization Holder
Farto S.r.l., Viale Guidoni 97, 50127 Florence, Italy

Manufacturer
Levonis 0.1% nebulizing solution
Genetic S.p.A. – Contrada Canfora – Fisciano (SA)

Levonis adults nebulizing solution
Levonis children nebulizing solution
Genetic S.p.A. – Contrada Canfora – Fisciano (SA)